October 2018 FDA Recall Drug by Zero Xtreme Usa
D-0246-2019 - Marketed Without an Approved NDA/ANDA

This Class II drug recall was voluntarily initiated by Zero Xtreme Usa on October 15, 2018 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0246-2019

Reason for Recall
Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine
Initiated
10-15-2018
Reported
11-21-2018
Quantity
16 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81436
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Zero Xtreme USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-18-2022
Product Description About Product Description
Full technical description of the product.
Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA

Batch or Lot Expiration Information

Lot# Lot: 1220062085 Exp. 03/2020